MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-03-15 for TRANSMOTION MEDICAL, INC TMM4-B manufactured by Transmotion Medical Inc..
[3364109]
No injury reported. No pts were event around, but reporting based on potential hazard. Customer called to state there was battery acid leaking from the battery while it was on the charger (which was left on the charger over the weekend). Dennis from biomed was the ultimate person that discarded the battery without returning to tmm for obvious reasons. He wasn't sure of any environmental issues on their end.
Patient Sequence No: 1, Text Type: D, B5
[10661226]
Tmm is choosing to replace this device and monitor as this is a very rare occurrence. First on record for tmm. Item has been replaced and all is working well. The only other time we've seen this is when the battery was clearly dropped/misused. This could have been the case, but couldn't validate via pictures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2013-00001 |
| MDR Report Key | 3050538 |
| Report Source | 06 |
| Date Received | 2013-03-15 |
| Date of Report | 2013-03-13 |
| Date of Event | 2013-01-03 |
| Date Mfgr Received | 2013-01-03 |
| Device Manufacturer Date | 2009-05-15 |
| Date Added to Maude | 2013-05-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1441 WOLF CREEK TRAIL |
| Manufacturer City | SHARON CENTER OH 44274 |
| Manufacturer Country | US |
| Manufacturer Postal | 44274 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL, INC |
| Generic Name | TMM4 MULTIPURPOSE STRETCHER-CHARI |
| Product Code | GBB |
| Date Received | 2013-03-15 |
| Model Number | TMM4-B |
| Catalog Number | TMM4-B |
| Lot Number | 2867 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSMOTION MEDICAL INC. |
| Manufacturer Address | 1441 WOLF CREEK TRAIL SHARON CENTER OH 44274 US 44274 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-15 |